Director, Small Molecule, Manufacturing Sciences and Technology

General Description:

This role in the Manufacturing Science and Technology (MST) department supports BeOne’s Small Molecule Manufacturing Plant, currently in the design phase. The position serves as the site Subject Matter Expert (SME) for Oral Solid Dose (OSD) manufacturing and provides technical leadership for facility design, equipment selection, and start-up activities. It is responsible for leading technology transfer, lifecycle validation, and technical support for commercial manufacturing. Reporting to the Sr. Director of MST, this onsite role is based at BeOne’s U.S. Manufacturing Site in Hopewell, NJ.

Essential Functions of the Job:

• Small Molecule expertise in OSD manufacturing processes, including wet granulation, drying, blending, tablet compression and coating.

• Familiarity with API manufacturing processes and specifications.

• Excellent technical writing skills, including authoring technology transfer plans, validation protocols/reports, Comparability Studies, and regulatory filing documents.

• Regulatory Health Authority experience such as inspections and/or Regulatory Submission, and correspondence.

• Investigate root causes of major deviations for cGMP manufacturing, and implement CAPA for major deviations

• Work with counterparts in Process Development, Process Sciences, Manufacturing, Quality, and CMC Project Management. to facilitate technology transfer and project success.

• Expertise in late stage/commercial Drug Product technology transfer, process characterization and process validation.

• Working knowledge of GMP and regulatory requirements of biopharmaceutical manufacturing.

• Ability to work both independently and as part of a team.

• Ability to function in a fast-paced dynamic team environment and balance prioritize multiple projects

• Excellent troubleshooting skills and ability to solve complex technical issues. Ability to compile, analyze and interpret data; Ability to write routine reports and correspondence.

• Strong interpersonal and communication skills, verbal and written. Ability to speak effectively before groups of customers. Ability to communicate in a dynamic environment.

Supervisory Responsibilities:

• Bachelor’s degree and 10+ years of pharmaceutical industry experience required

• Master’s degree and 7+ years of pharmaceutical experience preferred

• 7+ years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources.

• Ability to hire, train and develop a technical team to support facility start-up, technology transfer and commercial pharmaceutical manufacturing

• Ability to build departmental processes and procedures in support of life cycle validation and technical support.

• Cross-functional collaboration experience with key stakeholders including Manufacturing Operations, Quality Assurance/ Control (QA/QC), Facilities and Engineering (F&E) and Regulatory Compliance/ Regulatory Affairs.

• Project Leadership experience in fast-paced, complex environments with tight time and cost controls.

• Experience leading complex investigations, identification of root causes, and implementation of corrective actions.

• Technology Transfer leadership experience with new product introduction or commercial life cycle products.

• Life Cycle validation leadership, including Process Design, Process Qualification, and Continued Process Verification.

• Collaborate with Global CMC, MS&T and Technical Development to enable new DP manufacturing capabilities at Hopewell Location.

• Establish a data and metrics driven culture. Relentlessly maintain alignment with other global manufacturing sites through shared knowledge, shared manufacturing data, shared manufacturing issues, and common solutions.

Computer Skills:

• Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).

• Statistical software application experience preferred (JMP, minitab, etc)

Other Qualifications:

• Six sigma green/black belt preferred

Travel: Up to 10%

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.